Table 3.

 Adverse events occurring in 500 consecutive patients with Crohn’s disease treated with infliximab

Adverse event	Frequency
Serious adverse event	43 patients (8.6%)
Serious adverse event attributed to infliximab	30 patients (6%)
Acute infusion reactions	19 patients (3.8%)
Serum sickness-like disease	19 patients (3.8%)
Serum-like disease attributed to infliximab	14 patients (2.8%)
Drug induced lupus	3 patients (0.6%)
New demyelination disorder	1 patient (0.2%)
Any infectious event	48 patients (9.6%)
Any infectious event attributed to infliximab	41 patients (8.2%)
Serious infection	20 patients (4%)
Fatal sepsis	2 patients (0.4%)
Pneumonia	8 patients (1.6%) &;(2 were fatal)
Viral infections	6 patients (1.2%)
Abdominal abscess requiring surgery	2 patients (0.4%)
Cellulitis of the arm	1 patient (0.2%)
Histoplasmosis	1 patient (0.2%)
Malignant disorder	9 patients (1.8)
Malignant disorder possibly related to infliximab	3 patients (0.6%)
Deaths	10 patients (2.0%)
Deaths possibly related to infliximab	5 patients (1.0%)

Data from Colombel and colleagues.²⁰